Observing the safety of VYLOY in patients with gastric or GEJ cancer in South Korea
Official title: Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg, 300 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea
Run by Astellas Pharma Inc · NCT06902545 · Data updated 2026-11-12
This study is testing how safe the drug VYLOY is for people in South Korea with advanced stomach or gastroesophageal junction cancer who are receiving it as part of their regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 377 (estimated) |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Locations | 15 sites (Goyang-si, Gyeonggi-do and 14 other locations) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | July 31, 2030 |
| Study ends | July 31, 2030 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06902545 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients in South Korea with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma who are receiving VYLOY treatment.
✕Probably not a fit
Patients who have contraindications for VYLOY or are involved in other clinical trials with investigational drugs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on individuals in South Korea diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will receive VYLOY (zolbetuximab) as part of their standard treatment regimen, which is administered intravenously. The primary goal is to gather real-world data on the safety profile of VYLOY in this patient population, as well as to monitor the progression of their cancer over time.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of VYLOY for patients with gastric and GEJ cancers.
How similar studies have gone: Other studies have shown positive outcomes with similar treatments for gastric cancer, indicating that this approach is promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who receive treatment with VYLOY injection, according to the approved local label. Exclusion Criteria: * Patients with any contraindication for VYLOY injection, according to the approved local label. * Patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.
Where it's running
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Site KR82010
Goyang-si, Gyeonggi-do, South Korea Recruiting -
Site KR82008
Suwon, Gyeonggi-do, South Korea Recruiting -
Site KR82009
Suwon, Gyeonggi-do, South Korea Recruiting -
Site KR82014
Uijeongbu-si, Gyeonggi-do, South Korea Recruiting -
Site KR82006
Yangsan, Gyeongsangnam-do, South Korea Recruiting -
Site KR82012
Hwasun Gun, Jeollanam-do, South Korea Recruiting
Show 9 more locations
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Site KR82015
Daejeon, South Korea Recruiting -
Site KR82001
Seoul, South Korea Recruiting -
Site KR82002
Seoul, South Korea Recruiting -
Site KR82003
Seoul, South Korea Recruiting -
Site KR82004
Seoul, South Korea Recruiting -
Site KR82005
Seoul, South Korea Recruiting -
Site KR82007
Seoul, South Korea Recruiting -
Site KR82011
Seoul, South Korea Recruiting -
Site KR82013
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Astellas Pharma Global Development, Inc.
- Email: astellas.registration@astellas.com
- Phone: 800-888-7704
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Zolbetuximab plus pembrolizumab and chemotherapy for stomach and gastroesophageal junction cancer
This trial will test whether adding zolbetuximab to pembrolizumab and standard chemotherapy helps adults with Claudin 18.2-positive, HER2-negative locally advanced or metastatic stomach or gastroesophageal junction cancer.
-
Fruquintinib plus nab‑paclitaxel with iparomlimab and tuvonralimab for people with advanced gastric or GEJ cancer after immunotherapy
This trial tests whether adding fruquintinib and two immune drugs (iparomlimab and tuvonralimab) to nab‑paclitaxel helps people with advanced gastric cancer whose disease progressed after first‑line immunotherapy.
-
Lenvatinib with nivolumab and chemotherapy for metastatic gastric cancer with malignant ascites
This trial tests whether adding lenvatinib to nivolumab plus chemotherapy helps people with metastatic gastric or gastroesophageal junction adenocarcinoma who have peritoneal metastases and significant malignant ascites.
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Zolbetuximab with paclitaxel and ramucirumab for CLDN18.2-positive stomach and gastro‑esophageal junction cancer
This treatment tests whether adding zolbetuximab to paclitaxel and ramucirumab helps adults with metastatic gastro‑esophageal adenocarcinoma whose tumors are CLDN18.2‑positive live longer.
-
Testing BDC-4182 for advanced gastric and gastroesophageal cancer
This study is testing a new drug called BDC-4182 to see if it's safe and how well it works for people with advanced gastric and gastroesophageal cancer.
-
Investigating OKN4395 and Pembrolizumab for Solid Tumors
This study is testing a new drug called OKN4395, alone and with another drug called pembrolizumab, to see if it can help people with solid tumors who have run out of other treatment options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.